Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsule per Pac… recall
FDA recall D-0281-2025 · initiated Feb 20, 2025
One Source Nutrition, Inc, recalled Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsu… in Feb 2025 — an FDA Class I recall (D-0281-2025) because Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.
Sold unapproved, or found to contain something undeclared
The product should not have been on sale in this form — often a supplement found to contain a hidden prescription drug.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: a) 300 individually wrapped capsules b) 20 bottles
Details
- Product
- Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsule per Packet, b) 6 capsules per bottle, Xtreme Potency.
- Recalling company
- One Source Nutrition, Inc,
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the U.S.A
- Initiated
- Feb 20, 2025
- FDA report date
- Mar 26, 2025
Frequently asked
- Was Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsu… recalled?
- One Source Nutrition, Inc, recalled Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsu… in Feb 2025 — an FDA Class I recall (D-0281-2025) because Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsu… recalled?
- Per the FDA enforcement record, the reason for recall D-0281-2025 was: Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.
- Is a recalled Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsu… dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsu… are affected?
- Distributed: Nationwide in the U.S.A. The recall covers these lots — All lots. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0281-2025.